Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Observational Study
. 2016 Oct;68(10):1505-13.
doi: 10.1002/acr.22850. Epub 2016 Sep 2.

Sensitivity to Change and Minimal Important Differences of the LupusQoL in Patients With Systemic Lupus Erythematosus

Kathleen McElhone  1 , Janice Abbott  2 , Chris Sutton  2 , Montana Mullen  2 , Peter Lanyon  3 , Anisur Rahman  4 , Chee-Seng Yee  5 , Mohammed Akil  6 , Ian N Bruce  7 , Yasmeen Ahmad  8 , Caroline Gordon  9 , Lee-Suan Teh  10
Affiliations
Observational Study

Sensitivity to Change and Minimal Important Differences of the LupusQoL in Patients With Systemic Lupus Erythematosus

Kathleen McElhone et al. Arthritis Care Res (Hoboken). 2016 Oct.

Abstract

Objective: As a health-related quality of life (HRQOL) measure, the LupusQoL is a reliable and valid measure for adults with systemic lupus erythematosus (SLE). This study evaluates the responsiveness and minimal important differences (MIDs) for the 8 LupusQoL domains.

Methods: Patients experiencing a flare were recruited from 9 UK centers. At each of the 10 monthly visits, HRQOL (LupusQoL, Short Form 36 health survey [SF-36]), global rating of change (GRC), and disease activity using the British Isles Lupus Assessment Group 2004 index were assessed. The responsiveness of the LupusQoL and the SF-36 was evaluated primarily when patients reported an improvement or deterioration on the GRC scale and additionally with changes in physician-reported disease activity. MIDs were estimated as mean changes when minimal change was reported on the GRC scale.

Results: A total of 101 patients were recruited. For all LupusQoL domains, mean HRQOL worsened when patients reported deterioration and improved when patients reported an improvement in GRC; SF-36 domains showed comparable responsiveness. Improvement in some domains of the LupusQoL/SF-36 was observed with a decrease in disease activity, but when disease activity worsened, there was no significant change. LupusQoL MID estimates for deterioration ranged from -2.4 to -8.7, and for improvement from 3.5 to 7.3; for the SF-36, the same MID estimates were -2.0 to -11.1 and 2.8 to 10.9, respectively.

Conclusion: All LupusQoL domains are sensitive to change with patient-reported deterioration or improvement in health status. For disease activity, some LupusQoL domains showed responsiveness when there was improvement but none for deterioration. LupusQoL items were derived from SLE patients and provide the advantage of disease-specific domains, important to the patients, not captured by the SF-36.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Flow diagram of patient progress through study procedures.
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Urowitz MB, Gladman DD, Tom BD, Ibanez D, Farewell VT. Changing patterns in mortality and disease outcomes for patients with systemic lupus erythematosus. J Rheumatol 2008;35:2152–8. - PubMed
    1. Food and Drug Administration. Guidance for industry patient‐reported outcome measures: use in medical product development to support labeling claims. 2010. URL: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformati.... - PMC - PubMed
    1. Strand V, Gladman D, Isenberg D, Petri M, Smolen J, Tugwell P. Endpoints: consensus recommendations from OMERACT IV. Outcome measures in rheumatology. Lupus 2000;9:322–7. - PubMed
    1. McElhone K, Abbott J, Teh LS. A review of health related quality of life in systemic lupus erythematosus. Lupus 2006;15:633–43. - PubMed
    1. McElhone K, Castelino M, Abbott J, Bruce I, Ahmad Y, Shelmerdine J, et al. The LupusQoL and association with demographic and clinical measurements in patients with systemic lupus erythematosus. J Rheumatol 2010;37:2273–9. - PubMed

Publication types